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Data safety and monitoring board

AM Ameer Muhammad
ZF Zoha Zahid Fazal
BB Benazir Baloch
IN Imran Nisar
FJ Fyezah Jehan
YS Yasir Shafiq
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The independent group of experts, comprising of 5 members, constitutes the Data Safety and Monitoring Board (DSMB) for the trial and are responsible for monitoring safety indicators, adverse events, and results of the interim analysis. The interim analysis (blinded by arm) is scheduled for when 50% of the enrolled participants complete the 6-month follow-up. Only DSMB members will have access to the results of interim analysis, which will be shared by the independent statistician. Data on severe adverse events will be shared with the board on a monthly basis in the form of a progress report.

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